Pharmacokinetic-Pharmacodynamic Relationship of Metformin in Healthy Volunteers

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02712619

MP0

Details and patient eligibility

About

Two doses of metformin with 12 hour interval

• low dose group (375/250 mg)
• high dose group (1000/1000mg)

Full description

A study to evaluate and compare the pharmacokinetic-pharmacodynamic relationship between different metformin dose groups.

Enrollment: 20 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 20 to 45
• Body weight 50 to 100 kg
• fasting serum glucose 70 to 125 mg/dL
• who provide informed consent voluntarily

Exclusion criteria

• any significant renal, gastrointestinal, hepatic, and metabolic condition
• any co/prior medication within 14 days of study drug administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

metformin 250mg

Experimental group

Description:

metformin 375/250 mg

Treatment:

Drug: Metformin

metformin 1000mg

Experimental group

Description:

metformin 1000/1000 mg

Treatment:

Drug: Metformin